Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent
NCT ID: NCT00492908
Last Updated: 2014-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
303 participants
INTERVENTIONAL
2007-06-30
2013-08-31
Brief Summary
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Detailed Description
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Design: Prospective, multi-center, randomized, non-inferiority trial to be conducted at 3 Swiss interventional cardiology centers. Patients will be randomized in a single-blind fashion (1:1 randomization) to either the Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) or the Zotarolimus-Eluting Stent (EndeavorTm, Medtronic).
Study Population: Patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, unstable angina, and non-ST elevation myocardial infarction, who qualify for percutaneous coronary interventions
Antiplatelet Therapy: Aspirin 100 mg qd indefinitely; Clopidogrel 75 mg qd for 3 months
Enrollment: A total of 300 patients will be enrolled
All patients will undergo repeat angiography at 6-8 months.
All patients will be followed for up to 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Titanium Nitride Oxide Coated Stent
Stent
Helistent Titan2 (Titanium coated stent)
Titan2
Zotarohlimus Eluting Stent
Stent
EndeavorTM (Zotarolimus-Eluting Stent)
Endeavor
Interventions
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Helistent Titan2 (Titanium coated stent)
Titan2
EndeavorTM (Zotarolimus-Eluting Stent)
Endeavor
Eligibility Criteria
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Inclusion Criteria
1. Age ≥18 years
2. Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, unstable angina, and non-ST elevation myocardial infarction
3. Presence of one or more coronary artery stenoses \>50% in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents;
4. No limitation on the number of treated lesions, and vessels, and lesion length
Exclusion Criteria
2. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, titan, zotarolimus or contrast material
3. Inability to provide informed consent
4. Currently participating in another trial before reaching first endpoint
5. ST segment elevation myocardial infarction (STEMI)
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
University of Bern
OTHER
Responsible Party
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Bern University Hospital
Principal Investigators
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Stephan Windecker, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, University Hospital Bern, Bern, Switzerland
Locations
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Department of Cardiology, University Hospital Bern
Bern, , Switzerland
Countries
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References
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Windecker S, Simon R, Lins M, Klauss V, Eberli FR, Roffi M, Pedrazzini G, Moccetti T, Wenaweser P, Togni M, Tuller D, Zbinden R, Seiler C, Mehilli J, Kastrati A, Meier B, Hess OM. Randomized comparison of a titanium-nitride-oxide-coated stent with a stainless steel stent for coronary revascularization: the TiNOX trial. Circulation. 2005 May 24;111(20):2617-22. doi: 10.1161/CIRCULATIONAHA.104.486647. Epub 2005 May 9.
Windecker S, Mayer I, De Pasquale G, Maier W, Dirsch O, De Groot P, Wu YP, Noll G, Leskosek B, Meier B, Hess OM; Working Group on Novel Surface Coating of Biomedical Devices (SCOL). Stent coating with titanium-nitride-oxide for reduction of neointimal hyperplasia. Circulation. 2001 Aug 21;104(8):928-33. doi: 10.1161/hc3401.093146.
Pilgrim T, Raber L, Limacher A, Wenaweser P, Cook S, Stauffer JC, Garachemani A, Moschovitis A, Meier B, Juni P, Windecker S. Five-year results of a randomised comparison of titanium-nitride-oxide-coated stents with zotarolimus-eluting stents for coronary revascularisation. EuroIntervention. 2015 Mar;10(11):1284-7. doi: 10.4244/EIJY15M01_04.
Pilgrim T, Raber L, Limacher A, Loffel L, Wenaweser P, Cook S, Stauffer JC, Togni M, Vogel R, Garachemani A, Moschovitis A, Khattab AA, Seiler C, Meier B, Juni P, Windecker S. Comparison of titanium-nitride-oxide-coated stents with zotarolimus-eluting stents for coronary revascularization a randomized controlled trial. JACC Cardiovasc Interv. 2011 Jun;4(6):672-82. doi: 10.1016/j.jcin.2011.02.017.
Other Identifiers
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KEK237_06
Identifier Type: -
Identifier Source: org_study_id
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